Diabetes
Conditions
Brief summary
The purpose of this study was to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Interventions
DEVICENinja 3 PLUS Investigational BG Monitoring System
Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Males and females, 18 years of age or older. 2. People with type 1 or type 2 diabetes. 3. Able to speak, read and understand English. 4. Willing to complete all study procedures. *
Exclusion criteria
1. Hemophilia or any other bleeding disorder. 2. Pregnancy. 3. Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM. 4. Previously participated in a blood glucose monitoring study using the Ninja 3 Plus BGMS. 5. Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters. 6. Working for a competitive medical device company, or having an immediate family member who works for such a company. 7. A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results \<75mg/dL) and within +/- 20% (for reference BG results \>=75mg/dL) of the YSI reference method results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results \<100mg/dL) and within +/- 15% (for reference BG results \>=100mg/dL) of the YSI reference method results. |
| Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results \<100mg/dL) and within +/- 12.5% (for reference BG results \>=100mg/dL) of the YSI reference method results. |
| Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method. | 1 hour | Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) and within +/- 15% (\>=75mg/dL YSI capillary plasma). |
| Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff | one hour | Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results \<75mg/dL) and within +/- 20% (for reference BG results \>=75mg/dL) of the YSI reference method results. |
| Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | 1 hour | Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree.' |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Monitoring System Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method. | 113 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | unevaluable reference method results per | 1 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Customized Age of enrolled subjects | 59.1 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 responses |
| Race (NIH/OMB) Asian | 0 responses |
| Race (NIH/OMB) Black or African American | 26 responses |
| Race (NIH/OMB) More than one race | 1 responses |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 responses |
| Race (NIH/OMB) Unknown or Not Reported | 3 responses |
| Race (NIH/OMB) White | 84 responses |
| Region of Enrollment United States | 113 participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 113 |
| serious Total, serious adverse events | 0 / 113 |
Outcome results
Primary
Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method
Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results \<75mg/dL) and within +/- 20% (for reference BG results \>=75mg/dL) of the YSI reference method results.
Time frame: 1 hour
Population: 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method | 99.09 percentage of BG results |
Secondary
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements
Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree.'
Time frame: 1 hour
Population: Four subjects of those enrolled (113 subjects) had either missing or unevaluable questionnaire data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | I find it easy to do a blood test with this meter | 108 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | The meter display is easy to see and read | 108 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | It was easy to understand my test results | 108 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | I like the overall meter design | 106 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | I find the meter easy to use | 106 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | The instructions (User Guide) easy to understand | 105 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | Instructions clearly explain how to run a test | 107 participants |
| Intended Users of the Monitoring System | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | Instructions clearly explain meter error messages | 108 participants |
Secondary
Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method.
Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (\<75mg/dL YSI capillary plasma) and within +/- 15% (\>=75mg/dL YSI capillary plasma).
Time frame: 1 hour
Population: 209 (220-11) Blood Glucose results were analyzed. 2 subjects had low blood sugar and per protocol their 4 AST BG results were not evaluable. 3 BG results were excluded as they were protocol deviations. One subject (2 BG results) did not complete testing within protocol timeframe and one subject (2 BG results) was unable to obtain AST blood.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method. | 97.13 percentage of AST Blood Glucose Results |
Secondary
Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff
Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results \<75mg/dL) and within +/- 20% (for reference BG results \>=75mg/dL) of the YSI reference method results.
Time frame: one hour
Population: 220 Blood Glucose results were analyzed. Study Staff provided 2 Blood Glucose Test Results from each subject who completed (110 subjects) the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff | 100.0 percentage of Blood Glucose Results |
Secondary
Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method
Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results \<100mg/dL) and within +/- 12.5% (for reference BG results \>=100mg/dL) of the YSI reference method results.
Time frame: 1 hour
Population: 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method | 93.64 percentage of Blood Glucose Results |
Secondary
Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method
Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results \<100mg/dL) and within +/- 15% (for reference BG results \>=100mg/dL) of the YSI reference method results.
Time frame: 1 hour
Population: 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intended Users of the Monitoring System | Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method | 97.73 percentage of Blood Glucose Results |